ENSPRYNG (satralizumab) - (SatraGO)

30 June 2026: Roche (SIX: RO, ROP; OTCQX: RHHBY) said the FDA has accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) to treat thyroid eye disease (TED). The sBLA is supported by two randomized, placebo-controlled global Phase III trials, SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828), with data presented at ASOPRS in October 2025. The FDA decision is expected by 15 October 2026.

Across the SatraGO program, Enspryng showed improvements in key TED signs/symptoms including proptosis and diplopia. Primary endpoint (≥2 mm proptosis reduction at week 24) results: in SatraGO-2, 53% on Enspryng vs 23% on placebo achieved a proptosis response (statistically significant); in SatraGO-1, 49% vs 31% achieved response (numerical improvement, not statistically significant). Secondary measures included reductions in clinical activity score (CAS) for 78%–90% and diplopia improvement for 44%–61% across SatraGO-1/-2 in active TED. No new safety signals were identified; safety was consistent with the known profile in NMOSD.